Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
1
short-term treatment of insomnia
Key facts
- Sponsor
- Orion Corporation
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2026-05-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
short-term treatment of insomnia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10022437 | Insomnia | 100000004873 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Orion Corporation
- Sponsor organisation
- Orion Corporation
- Address
- P. O. Box 65
- City
- Espoo
- Postcode
- 02101
- Country
- Finland
Scientific contact point
- Organisation
- Orion Corporation
- Contact name
- clinical department
Public contact point
- Organisation
- Orion Corporation
- Contact name
- clinical department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-01 | Czechia | Acceptable 2026-05-05
|
2026-05-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-25 | Czechia | Acceptable 2026-05-05
|
2026-05-25 |